Efficacy and Safety of DBS in Patients With Primary Dystonia

August 5, 2024 updated by: Beijing Pins Medical Co., Ltd

Subthalamic Nucleus (STN) and Globus Pallidus Internus (GPi) Deep Brain Stimulation (DBS) in Patients With Primary Dystonia（RELAX Study）

The purpose of this study is to evaluate the safety and effectiveness of deep brain stimulation (DBS) of the subthalamic nucleus (STN) and globus pallidus internus (GPi) for primary dystonia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dystonia is an uncommon brain disorder in which there is abnormal muscle tone producing twisting, writhing movements and abnormal postures. It is associated with abnormal electrical activity in two groups of nerve cells in the brain called the globus pallidus internus (GPi) and the subthalamic nucleus (STN). GPi DBS appears to be effective for medication-refractory focal and segmental dystonia affecting the cranial and cervical regions in open-label series, but recently GPi stimulation has been associated with subtle motor disturbances in previously non-dystonic body regions (i.e., arms and legs) in this population of patients. DBS of the STN has also been reported to be effective for treating generalized and cervical dystonia in small open label trials. STN DBS for cranial and cervical regions may provide similar efficacy in the treatment of dystonia as GPi DBS, but without unwanted stimulation-induced motor effects. Objectives of this study is to evaluate the safety and efficacy of STN-DBS and GPi-DBS for dystonia; Participants will be evaluated pre- and postoperatively with standard dystonia rating scales including the Burke-Fahn-Marsden Dystonia rating scale (BFMDRS), Changes in cognitive function will be assessed with neuropsychological testing. Stimulation parameters will be documented, and a patient questionnaire will be administered postoperatively to determine if patients are experiencing stimulation-induced motor adverse effects. Patient weight will be recorded at study visits. This pilot study will provide preliminary open label efficacy outcomes for STN DBS in the treatment of primary dystonia and will help determine if this target should be compared to GPi DBS in a larger double-blind trial.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Union Medical College Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing Brain Hospital
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
    • Shanghai
      • Shanghai, Shanghai, China
        • Tongji Hospital of Tongji Univeristy
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Refractory primary (systemic, segmental) dystonia diagnosed by a movement disorders neurologist
  2. Severe functional impairment despite optimal medical management, including failed botulinum toxin therapy
  3. Ability to follow up with post-operative study visits
  4. Patients and their relatives have reasonable surgery expectations
  5. Volunteer to participate in clinical trials, and signed consent form
  6. Age 6-60 years

Exclusion Criteria:

  1. Pregnancy or plan a pregnancy
  2. Good treatment with Non-invasive therapy
  3. Dopamine reactive dystonia ，Genetic degeneration ，Paroxysmal dystonia ，Secondary dystonia， Psychogenic dystonia
  4. Brain MRI showing extensive brain atrophy or small vessel ischemic disease
  5. Cognitive impairment(MMSE<24)
  6. Severe depression or other serious mental illness
  7. History of traumatic brain injury, tumor, or severe cerebrovascular disease
  8. Severe brain atrophy (diagnosed by CT or MRI)
  9. Hyperthermia therapy in implant parts
  10. Abnormal in blood inspection, blood clotting disorders, liver and kidney dysfunction, or other clinical judgment cannot tolerate surgery
  11. High blood pressure, serious heart diseases, or respiratory diseases
  12. Diabetes
  13. Long-term treatment of immunosuppressive or hormones
  14. Implant pacemakers, defibrillators, cochlear and other nerve stimulators
  15. Other diseases need frequent MRI examinations
  16. Participated in any other clinical trials within 3 months
  17. Reluctant or unable to implant surgery
  18. Reluctant or unable to cooperate with follow-up
  19. Other exclusion Criteria by researchers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STN
DBS target with Subthalamic Nucleus (STN).
Device: Beijing Pins Medical Co., Ltd. Deep Brain Stimulator
Deep Brain Stimulation for primary dystonia subjects
Experimental: GPi
DBS target with Globus Pallidus Internus (GPi).
Device: Beijing Pins Medical Co., Ltd. Deep Brain Stimulator
Deep Brain Stimulation for primary dystonia subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) movement score
Time Frame: 3，6 months
3，6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-Form General Health Survey (SF-36)
Time Frame: 3，6 monthsthe Beck Anxiety Inventory31 (with scores ranging from 0 to 63 and higher scores indicating more severe anxiety)
Quality of life was assessed with the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36), which evaluates both physical and mental components of functioning on a scale of 0 to 100, with higher scores indicating a higher level of function.
3，6 monthsthe Beck Anxiety Inventory31 (with scores ranging from 0 to 63 and higher scores indicating more severe anxiety)
Visual analogue scale
Time Frame: 3，6 months
The severity of dystonia and pain was assessed with the use of a visual analogue scale, with scores ranging from 0 to 10 and higher scores indicating greater severity
3，6 months
Measurements of walking
Time Frame: 3，6 months
Measurements of walking (the duration and number of steps taken in a 14-m walk with one turn)
3，6 months
The Beck Depression Inventory
Time Frame: 3，6 months
The Beck Depression Inventory (with scores ranging from 0 to 63 and higher scores indicating more severe depression)
3，6 months
The rate of improvement of BFMDRS score
Time Frame: 3，6 months
The rate of improvement of BFMDRS score that >25%、>50%、>75%
3，6 months
Mini-Mental State Examination
Time Frame: 3，6 months
Cognitive were assessed by mini-mental state examination
3，6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Pins Medical Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2017

Primary Completion (Actual)

September 13, 2020

Study Completion (Actual)

December 17, 2021

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimated)

January 11, 2017

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 5, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINS-023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data is available upon request.

IPD Sharing Time Frame

De-identified data may be available after results have been published

IPD Sharing Access Criteria

Individual participant data is available upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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